Effectiveness of Abdominal Binder Use During Colonoscopy

Performance and Tolerance of Colonoscopy Clinical Trial

Official title:

Does Using Abdominal Binder Really Benefit During Colonoscopy ?: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383132
• Other study ID #: Beslen-korse
• Status: Completed
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: October 2020
• Source: Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Colonoscopy is considered the primary screening test for colorectal cancer screening worldwide. For technical difficulties previously experienced during colonoscopy, especially loop of the colonoscopy device in the colon, many solution methods have been developed and applied (manual pressure and position change, etc.). Although these methods are partially successful, there is no consensus on the optimum solution method. Few studies in the literature have investigated the use of corset during colonoscopy and conflicting results have been reported. In this study, elastic abdominal corset or false corset will be used during colonoscopy. Indeed, the investigators aim to determine whether this method is effective and safe with their own results and contribute to the literature. The primary outcome of this study will be the cecal intubation time. Secondary outcomes include manual pressure and position change during the procedure, length of cecal intubation (length of colonoscope required to reach the cecum from the anus), colonoscopy completion rate, additional anesthesia and / or analgesic requirement, patient pain and comfort level and colonoscopic findings.Efficacy will be assessed on the basis of pairwise comparisons between groups with respect to primary and secondary outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

Between the ages of 18 - 90 Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure, and describe adequate cleansing.

Participants with ASA I-III (American Society of Anesthesiologists Class III)

Exclusion Criteria:

Previous colon resection History of intra-abdominal malignancy Known anesthetic or analgesic drugs allergy Multiple planned procedures (e.g.bidirectional endoscopy) Pregnancy Active inflammatory bowel disease A history of intraabdominal malignancy History of cirrhosis or ascites Known ventral hernia

Related Conditions & MeSH terms

• Performance and Tolerance of Colonoscopy

Intervention

Device:
• Abdominal Binder
abdominal binder is a kind of elastic abdominal compression device

Locations

Country	Name	City	State
Turkey	Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Cecal Intubation Time	Cecal intubation time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum	During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified,an average of 1-30 minutes
Secondary	Number of Participants Who Required Ancillary Maneuvers	Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded.	During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes
Secondary	Length of Cecal Intubation	The length of the colonoscope required to reach the cecum from the anus will be measured	From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes
Secondary	Number of Participants Who Completed the Procedure	Dichotomous outcome indicating if the procedure was incomplete or complete.	During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes
Secondary	Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug	Whether the patient needs an additional dose of anesthetic and / or analgesic drug to complete the colonoscopy	During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes
Secondary	Patient Pain and Comfort Level at Discharge	Study assistant will interview patient just prior to discharge and obtain responses for pain according to 10-point visual analog scales ( scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" =1 (min) and "worst pain"=10 (max)) and global satisfaction according to a 5-point scale ( scores are recorded by making a handwritten mark on a 5-cm line that represents a continuum between "very unsatisfied" =1 (min) and "very satisfied"=5 (max) )	At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes
Secondary	Number of Participants According to Colonoscopy Findings	Findings such as polyp, cancer, diverticulum detected during colonoscopy will be recorded.	During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes